Clinical Research Coord II
Job Summary Under minimal supervision of the Manager, the Clinical Research Coordinator (CRC) II will implement and coordinate research and administrative procedures for the successful management of clinical trials. The CRCII will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable. Minimum Qualifications Education/Training Bachelor's Degree or an allied health or related professional degree and/or equivalent work experience. Experience 2 years of relevant clinical research experience. Experience in a healthcare setting preferred. Undergraduate and/or work experiences that demonstrates aptitude for research facilitation. License/Certification/Registration No special certification, registration or license required. Knowledge, Skills & Abilities Verbal and written communication skills. Basic computer skills preferred. Primary Duties and Responsibilities Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards and safety standards. Complies with governmental and accreditation regulations. Regulatory responsibilities include the oversight and/or responsibility for the Intuitional Review Board (IRB) submissions, and other related regulatory forms (eg, scientific review), and adhering to the timelines of the study start-up process; developing informed consent documents and other documents as applicable; supporting the safety of clinical research participants; ensureing the appropriate delegation of study related tasks (ie, Delegation of Authority). Explains the informed consent process and the study to the research participant (eg, purpose, duration, risks/benefits) and obtains all required signatures; ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent. Develops an effective recruitment plan (eg, central recruitment core); recruits research participants and discuss study protocol; educates research participants about protocol expectations and meets with research participants for each visit and maintains accessibility to discuss any questions or concerns regarding the study; oversees the development of advertising materials; participates in teleconferences and/or meetings to review study progress and conduct. Data entry responsibilities include the completion and maintenance of case report forms and reviews data against the research participant's medical record for completeness and accuracy; addressing all queries, clarifications and outstanding data queries and appropriately communicating with the sponsor and/or Contract Research Organization (CRO); completing and submitting case report forms on as close to a "real time basis" as possible. Ensures proper collection, processing and shipment of biospecimens and pharmacokinetics as applicable (eg, centrifuge, freezing, refrigeration) and maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens; assists with maintaining equipment (eg, calibration, preventive maintenance); communicates with manager, investigator and sponsor regarding abnormal laboratory values; maintains Internal Air and Transportation Association (IATA) training for routine packaging, labeling and transporting of biological materials. Study conduct responsibilities include research participant interviews and assessments at study visits as required by protocol; assessing and ensuring research participant safety through study participation; maintaining close communication with investigator; attending investigator meetings as appropriate and communicating relevant information to the research team; understanding and proficiently communicating all components of research documents, such as protocol, investigator brochure and research instructions. Receives and maintains test articles from sponsor and inventory test articles; works with research pharmacist as applicable; stores test article supplies according to Food and Drug Administration (FDA) regulations and sponsor requirements; administers test article as appropriate; retrieves test articles and calculates research participant compliance; maintains randomization and emergency codes of test article; documents on accountability log and research participant record (eg, test article received, used, disposed). Ensures that non-serious and serious adverse events are properly identified, documented and reported according to all applicable requirements; presents investigator with relevant information for determination of seriousness, causality and intervention; acts on investigator's recommendation for adverse event intervention (eg, stop test article, call research participant, re-test, treat); maintains follow-up to determine resolution of adverse event. Understands and complies with rules for billing Medicare, Medicaid and third party payors for services, drugs, devices, tests and procedures rendered in the clinical research context; responsible for reviewing, understanding and accepting the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies; ensures research participant stipends have been routed in a timely manner as applicable. Study close-out responsibilities include return or disposition of unused supplies per sponsors requirement; reconciling test article accountability; document research participants who are lost to follow-up or who have dropped out (eg, causes, contact efforts); ensuring long term storage of documents; submitting IRB closing report (ie, termination) after sponsor has closed study site. Acts as a liaison with research participants, investigators, sponsors and healthcare professionals; prepares for site qualification, study initiation, monitoring and close-out visits; ensures all research participant encounters are updated as appropriate and within one business day in clinical trial management system (CTMS); works effectively with multidisciplinary, ancillary and inter-professional research teams; posseses a basic understanding of scientific center goals and the importance of serving our customers. Must comply with federal, state an sponsor policies; must comply with institutional policies, procedures and guidelines; must possess working knowledge of the ethical treatment of research participants, aspects of human protection and safety in the conduct of clinical research (21 CFR 50 Protection of Human subjects, 21 CFR 54 Financial Disclosure, 21 CFR 56 Institutional Review Boards, 21 CFR 312 Investigational new Drug Application [IND], 21 CFR 812 Investigational Device Exemption [IDE], 21 DFR 600 Biological Products). Must possess basic understanding Good Clinical Practices (GCP) provided by the International Conference on Harmonization (ICH); required trainings such as Collaborative Institutional Training Initiative (CITI), Conflict of Interest (COI), and annual MedStar Health mandatory's. Participates in multidisciplinary quality and service improvement teams as appropriate. Participates in meetings, serves on committees and represents the department and hospital/facility in community outreach efforts as appropriate. Performs other duties as assigned. About MedStar Health MedStar Health is dedicated to providing the highest quality care for people in Maryland and the Washington, DC, region, while advancing the practice of medicine through education, innovation and research. Our 30,000 associates and 5,400 affiliated physicians work in a variety of settings across our health system, including 10 hospitals and more than 300 community-based locations, the largest visiting nurse association in the region, and highly respected institutes dedicated to research and innovation. As the medical education and clinical partner of Georgetown University for more than 20 years, MedStar is dedicated not only to teaching the next generation of doctors, but also to the continuing education and professional development of our whole team. MedStar Health offers diverse opportunities for career advancement and personal fulfillment.